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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01695343




Registration number
NCT01695343
Ethics application status
Date submitted
25/09/2012
Date registered
27/09/2012
Date last updated
14/01/2015

Titles & IDs
Public title
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa
Secondary ID [1] 0 0
KB001A-05
Universal Trial Number (UTN)
Trial acronym
KB001-A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - KB001-A
Treatment: Drugs - Placebo Comparator

Experimental: KB001-A - KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.

Placebo Comparator: Placebo Comparator - Placebo administered up to 5x intravenously


Other interventions: KB001-A


Treatment: Drugs: Placebo Comparator


Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms. - Time-to-need for ABX treatment will be the length of time between study material dosing and administration of ABX as needed for worsening respiratory conditions.
Timepoint [1] 0 0
16 Weeks
Secondary outcome [1] 0 0
Safety and tolerability of KB001-A - Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments
Timepoint [1] 0 0
16 Weeks

Eligibility
Key inclusion criteria
- Individuals with CF who are older than 50 years of age may participate if treated with
2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms
(CF exacerbation) in the 12 months before the Screening Visit

- Confirmed diagnosis of CF

- At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The
most recent positive Pa culture must be within 12 weeks before the Screening Visit (or
obtain a positive culture at screening)

- FEV1 % levels within acceptable ranges (per the study protocol)

- Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the
Day 0 Visit
Minimum age
12 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit

- Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit

- Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0
Visit

- History of sputum cultures positive for B. cepacia complex in the 2 years before the
Screening Visit

- History of organ transplantation

- Current smoker (tobacco, marijuana, or any other material). Use of smokeless
inhalers/vaporizers for these materials is also prohibited

- History of drug addiction or alcohol abuse in the 12 months before the Screening Visit

- History of hepatic disease (clinical cirrhosis or portal hypertension), renal
dysfunction

- Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test

- Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0
Visit, whichever is longer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- New Lambton
Recruitment hospital [2] 0 0
- Parkville
Recruitment hospital [3] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Maine
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Hampshire
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New Mexico
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New York
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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United States of America
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Wisconsin
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Israel
State/province [30] 0 0
Haifa
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Israel
State/province [31] 0 0
Jerusalem
Country [32] 0 0
Israel
State/province [32] 0 0
Petah-Tikva
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Hashomer
Country [34] 0 0
New Zealand
State/province [34] 0 0
Dunedin
Country [35] 0 0
New Zealand
State/province [35] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Humanigen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway
anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway
infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway
Pa infection will be safe and well-tolerated, and will increase the time-to-need for
antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and
symptoms compared with placebo.
Trial website
https://clinicaltrials.gov/show/NCT01695343
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nestor A. Molfino, MD., MSc
Address 0 0
KaloBios Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications